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Data from a pooled post hoc analysis of 14 placebo-controlled, dapagliflozin treatment studies in patients with type 2 diabetes with and without anemia at baseline
Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands ; George Institute for Global Health, Sydney, Australia.
George Institute for Global Health, Sydney, Australia ; Department of Renal Medicine, University College London, United Kingdom.
Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.
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2021 (English)In: Data in Brief, E-ISSN 2352-3409, Vol. 37, p. 1-11, article id 107237Article in journal (Refereed) Published
Abstract [en]

Dapagliflozin is a highly selective sodium-glucose cotransporter 2 inhibitor associated with stabilization of estimated glomerular filtration rate (eGFR); reductions in glycated hemoglobin (HbA1c), systolic blood pressure, body weight, and albuminuria; and a small and consistent increase in hematocrit [1–4]. This data set is based on the associated article [5] analyzing data from 5325 patients with type 2 diabetes from 14 placebo-controlled, phase 3 (one phase 2/3), double-blind dapagliflozin treatment studies of 24–104 weeks’ duration. Data on dapagliflozin's effects (vs. placebo) on hemoglobin (Hb), hematocrit, serum albumin, serum total protein concentrations, urine albumin/creatinine ratio, eGFR, heart rate, blood pressure, body weight, and safety in patients with type 2 diabetes with and without anemia were pooled and analyzed. Patients were divided into two groups according to baseline Hb levels: anemia (Hb <13 g/dL in men and <12 g/dL in women) and no anemia. Some biomarkers associated with erythropoiesis and the presence of anemia, such as iron, transferrin, ferritin, reticulocytes, and hepcidin, were not included in the original studies and therefore data for these biomarkers were not available. Descriptive statistics were used for baseline characteristics and safety data and a longitudinal repeated-measures mixed model for efficacy data. Changes in Hb concentrations were evaluated, and the proportion of patients with baseline anemia who were no longer anemic at week 24 was determined, as was the occurrence of polycythemia (Hb >16.5 g/dL in men and >16.0 g/dL in women). Because anemia commonly occurs in patients with diabetes and chronic kidney disease [6], the data can be of value to further analyze trends in relevant physiological and pathophysiological parameters.

Place, publisher, year, edition, pages
Elsevier, 2021. Vol. 37, p. 1-11, article id 107237
Keywords [en]
Anemia, Chronic kidney disease, Dapagliflozin, eGFR, Hematocrit, Hemoglobin, SGLT2 inhibitor, Type 2 diabetes
National Category
Bioinformatics and Systems Biology
Research subject
Bioinformatics
Identifiers
URN: urn:nbn:se:his:diva-20212DOI: 10.1016/j.dib.2021.107237ISI: 000689359300003PubMedID: 34258337Scopus ID: 2-s2.0-85108879138OAI: oai:DiVA.org:his-20212DiVA, id: diva2:1579081
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AstraZeneca
Note

CC BY 4.0

Corresponding author: E-mail address: correarotter@gmail.com (R. Correa-Rotter).

Available from: 2021-07-08 Created: 2021-07-08 Last updated: 2021-10-26Bibliographically approved

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Sartipy, Peter

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